Who is sponsoring NCT00300456?

NCT00300456 is sponsored by Abbott.

What condition does NCT00300456 study?

NCT00300456 studies Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia.

What drugs are being tested in NCT00300456?

Interventions: ABT-335, Simvastatin, Placebo.

What is the status of NCT00300456?

NCT00300456 is currently COMPLETED.

Last reviewed 2009-05-29 · How we verify

A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 and Simvastatin Combination Therapy to ABT-335 and Simvastatin Monotherapy in Subjects With Mixed Dyslipidemia

NCT00300456 Phase 3 COMPLETED Results posted

The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.

Details

Lead sponsor	Abbott
Phase	Phase 3
Status	COMPLETED
Enrolment	657
Start date	2006-03

Conditions

Dyslipidemia
Coronary Heart Disease
Mixed Dyslipidemia

Interventions

ABT-335
Simvastatin
Placebo

Primary outcomes

Mean Percent Change in Triglycerides From Baseline to Final Visit — Baseline to 12 Weeks (Final Visit)
\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\] x 100
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit — Baseline to 12 Weeks (Final Visit)
\[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C\] x 100
Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit — Baseline to 12 Weeks (Final Visit)
\[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C\] x 100

Countries

United States